COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04348695

Not reported

Not reported

2020-04-16

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - patients who have given their written informed consent. if it is considered that obtaining written consent could constitute a factor for the transmission of the disease (given the high contagiousness of the sars-cov-2 virus), it will be permitted to obtain duly justified verbal consent in the patient's medical history. - clinical diagnosis or confirmed by analytical tests (pcr of viral rna or detection of antisars-cov-2 antibodies) that requires care in hospital and that are grade 3 or 4 of the who 7-point ordinal scale of severity categorization for covid. - platelets> 50,000 / ul, neutrophils> 500 / ul - kidney or liver failure is not a contraindication, dose adjustment will be made according to the smpc - women of childbearing potential who are sexually active, not undergoing a hysterectomy or double adnexectomy, should follow the following indications for contraception: - negative serum or urine pregnancy test in the 72 hours prior to the start of treatment. - use of a medically accepted contraceptive method during: 2 months prior to the start of study treatment, during the study and up to 3 months after the last dose of treatment.

- documented concomitant severe bacterial or fungal infection - infection with hiv, hcv, hbv - age <18 years - thrombocytopenia <50,000 / ul, neutropenia <500 / ul - women of childbearing age who do not use an effective contraceptive method. - pregnant or lactating women. - patients who do not want or cannot comply with the protocol. - patients with impaired gastrointestinal function or gastric disease that significantly impairs the absorption of ruxolitinib or simvastatin, such as: severe ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, extensive resection (> 1m) of the small intestine or inability to swallow oral medication. previous partial or total gastrectomy is not an exclusion criterion

2

Fundación de investigación HM

18

None

Spain

Mild disease at enrollment

1: Mild disease at enrollment

94

Percentage of patients who develop severe respiratory failure.

None

Phase 2

[{"arm_notes": "", "treatment_id": 1698, "treatment_name": "Ruxolitinib+simvastatin", "treatment_type": "Kinase inhibitors+metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]